Protection device for protecting an injection needle

ABSTRACT

The present invention relates to a protection device ( 1 ) intended to at least partially cover the needle ( 2 ) of an injection device, comprising: a support ( 3 ) of the protection device ( 1 ), a sleeve ( 4 ) movable axially in translation with respect to the support ( 3 ), an arrangement ( 14 ) for returning the sleeve ( 4 ) from an injection position to a protection position, an axial guidance arrangement ( 29, 30 ) for preventing the sleeve ( 4 ) from pivoting with respect to the support ( 3 ), one peg ( 6 ) directly and at least elastically, coupled longitudinally to the support ( 3 ) or the sleeve ( 4 ) and housed in a passageway ( 10 ) defining a first section ( 11 ) and a second section ( 12 ) followed by the peg ( 6 ) from a storage position to the injection position and then to the protection position, and a safety arrangement ( 21; 36, 34, 35 ) part of which being elastically deformable, arranged in a way as to prevent the peg from returning from the second section to the first section. The invention also relates to packaging ( 26 ) for the device.

FIELD OF THE INVENTION

The present invention relates to a protection device for protecting aneedle so as to protect the patient and/or the user from the risk ofneedlestick injury, particularly after the said needle has been used.

BACKGROUND OF THE INVENTION

In the medical field, syringes may be supplied ready for use or in theform of kits to be assembled, which may or may not be pre-filled withthe liquid that is to be injected. Thus, the liquid that is to beinjected is often supplied within a syringe body containing the dosethat is to be injected. The end of the syringe body may be provideddirectly with a needle or may be provided with a syringe tip to which aneedle support bearing the needle can be fixed. This syringe tip is, forexample, of the “luer” or “luer lock” type. These syringes, syringe tipsand needle supports are preferably “single-use” items so as to limit therisk of contaminating the patients and/or the care personnel withequipment that has already been used.

In this field, it is also of prime importance that the patients andusers be protected from any risk of needlestick injury, particularlybetween the moment that injection is finished and the discarding of theinjection device. Sleeves that protect the needles and that areactivated manually after injection exist but in order to render theoperation of protecting the needle more reliable and easier for theuser, attempts have been made to render automatic the placement of theprotective sleeve around the needle at the moment the needle iswithdrawn from the injection site.

Document EP 409 180 describes a device for protecting a needlecomprising a moving sleeve intended to cover the needle after injection.However, this protection device entails the sleeve rotating on itself bya certain amount in order to trigger its deployment, this rotation beingperformed while the distal end of the sleeve is in contact with thepatient's skin, and while the medicinal product is being injected.

Thus, in such a case, because of the rotating of the sleeve, anundesirable feeling of friction against the skin and/or of instabilityof the injection device is perceived by the patient and/or by the user.This results in a notable impediment to the giving of the injection. Asthe injection cannot then be administered under optimal conditions, thepatient and/or the user are reluctant to use the safety devicesconcerned and this often causes them to put themselves in unsafeinjecting conditions. This solution is therefore not satisfactory.

There therefore remains a need for a device for protecting a needle,without additional manual intervention on the part of the user and whichdoes not give rise to an effect of friction against the patient's skin.

SUMMARY OF THE INVENTION

The present invention aims to satisfy this need by proposing a devicefor protecting a needle that is effective, reliable with safetyoperation not directly linked to friction specificities, easy tomanufacture and to use, comprises a limited number of parts, can beactivated after injection without additional manual intervention on thepart of the user so as to cover the needle, the said needle protectiondevice not giving rise to any effect of friction against the patient'sskin and limiting the risks of needlestick injury. In order to increasethe safety of the injection, the present invention is also aimed atproposing such a needle protection device that is irreversible,preventing access to the needle once it has been activated. The presentinvention is also aimed at proposing a needle protection device that canbe used in any field of medicine, veterinary science and with anyinjection device such as, for example, syringes, catheters and any otherequivalent device.

The present invention relates to a protection device intended to atleast partially cover the needle of an injection device, the saidprotection device comprising at least:

-   -   a support provided with fixing means intended to secure the said        protection device to an injection device,    -   a sleeve comprising a distal end intended to come into contact        with an injection surface and provided with an orifice intended        to allow the said needle to pass, the said sleeve being arranged        in such a way as to be moveable axially in translation with        respect to the said support from a first position known as the        storage position, in which the distal end of the said sleeve is        at a distance 1 ₁ from the said fixing means, to a second        position known as the injection position, in which the distal        end of the said sleeve is at a distance 1 ₂ from the said fixing        means, and to a third position known as the protection position,        in which the distal end of the said sleeve is at a distance 1 ₃        from the said fixing means, the said distances 1 ₁ and 1 ₃ being        greater than the said distance 1 ₂,    -   first return means for returning the said sleeve at least from        its injection position to its protection position, characterized        in that the said protection device comprises at least:    -   axial guidance means for guiding the said sleeve, arranged in        such a way as to prevent it from pivoting axially as it moves        axially with respect to the said support at least from its        injection position to its protection position,    -   at lest one peg, directly and at least elastically, coupled        longitudinally to the said support or to the said sleeve and        housed in a running passageway provided respectively in the said        sleeve or in the said support, the said running passageway        forming more or less a U, of which the branches respectively        define a first section taken by the said peg as the said sleeve        moves from its storage position to its injection position and a        second section taken by the said peg as the said sleeve passes        from its injection position to its protection position, the said        peg being designed to be laterally mobile,    -   first safety means, at least part of them being elastically        deformable, said first safety means being arranged in such a way        as to prevent the said peg from returning from the said second        section to the said first section.

The protection device according to the invention is able to protectefficiently the needle of an injection device, at least after injection.Particularly by virtue of the presence of a peg that can move laterallyand which is longitudinally linked to the support, the impact offriction problem due to moving parts and that is encountered in otherprior art protection devices, is avoided. Therefore, the protectiondevice according to the invention is a more reliable protection device.

Furthermore, because the sleeve of the device according to the inventiondoes not rotate on itself during the entire operation of administeringthe medicinal product, the injection is at no time disrupted by theeffect of friction against the patient's skin, it is therefore easierand safer and can be administered without inconveniencing either of thepatient or the user.

In addition, the protection device according to the invention makes itpossible to avoid the risks of needlestick injury after injection as theneedle is withdrawn from the injection site. What happens, afterinjection, as the injection device is withdrawn, is that the returnmeans allow deployment of the sleeve without the user having to performany additional manual operation. The operation of triggering theplacement of the sleeve is therefore also safe.

The present invention also relates to an injection device comprising aneedle protection device described hereinabove.

By virtue of the features of the invention, it is possible to supply aninjection device ready for use and provided with the said protectiondevice, it being possible for the end of the needle of the injectiondevice to be visible, but nonetheless safe. Indeed, it may be importantto nurses to have an injection device in which the end of the needle isvisible: that allows them to expel air prior to most injections, withthe best possible view of what they are doing. That also allows thembetter control over the first phase of the operation of injecting themedicinal product, namely the phase of positioning the needle on theinjection site and orientating the tip of the needle with a view toinserting it and injecting the medicinal product.

In this application, the distal end of a component or a device is to beunderstood as meaning the end furthest from the user's hand and theproximal end is to be understood as meaning the end closest to theuser's hand. Likewise, in this application, the “distal direction” is tobe understood as meaning the direction of injection, and the “proximaldirection” is to be understood as meaning the opposite direction to thedirection of injection.

Within the meaning of this application, the “injection surface” may bethe patient's skin in the case of an injection, the membrane of a bottlefrom which the product is taken or in which it is mixed, the end of atube, of a pipe, the wall of a flexible bag, or of any connecting means.

The expression “able to move laterally” is to be understood, within thecontext of the current application, as meaning that the peg can move ina rectilinear or linear fashion in a plane perpendicular to the axis ofthe device, or in a circular fashion in a plane parallel to the axis ofthe device.

As a preference, the said axial-guidance means are arranged in such away as also to prevent the said sleeve from pivoting axially as it movesaxially with respect to the said support from its storage position toits injection position.

Advantageously, the said axial-guidance means comprise more or lesscomplementary longitudinal geometric shapes provided respectively on thesaid sleeve and on the said support and arranged facing one another inorder to collaborate. These geometric shapes may be grooves, ribs,bulges or alternatively slideways.

As a preference, the said first and second sections of the said runningpassageway are joined together by a first narrowed region defined by aflexible tongue at least partially defining the said first safety means.

Advantageously, the peg may be solid and made of a deformable material;it may be hollow, its walls deforming inwards, or may be formed offlexible tabs.

Advantageously, the said peg is urged laterally from the said firstsection towards the said second section by second return means at leastpartially defining the said first safety means.

As a preference, the said support or, respectively, the said sleevecomprises at least one tab able to deflect tangentially and bearing thesaid peg. Advantageously, the said tab is arranged in such a way as todeflect tangentially in an elastically deformable manner between anormal position and at least one stressed deflected position, said tabat least partially defining the said first safety means.

For example, the said tab is in a normal position or, respectively, in astressed deflected position when the said peg is in the said firstsection, and the said tab is in the stressed deflected position or,respectively, in the normal position when the said peg is in the saidsecond section. The said tab may be made of an elastically deformablematerial. The said tab may also comprise a pivot connection or a balljoint, which is elastically deformable, it being possible for thisconnection to be coupled to these return means.

As a preference, the said first and second sections have differentlengths arranged in such a way as to delimit the said storage andprotection positions such that the said distance 1 ₃ is greater than thesaid distance 1 ₁.

As a preference, facing the said running passageway provided on the saidsleeve or, respectively, on the said support, the said support or,respectively, the said sleeve comprises a deflection passage arranged insuch a way as to guide the said peg laterally.

In one embodiment of the invention, the said protection device comprisessecond safety means arranged in such a way as to block the said peg whenthe said sleeve is in the said protection position.

As a preference, the said second section of the said running passagewaycomprises a second narrowed region at least partially defining the saidsecond safety means.

Advantageously, the said second section of the said running passagewaycomprises at least one step forming a stop catch for the said peg whenthe said sleeve is in the said protection position and at leastpartially defining the said second safety means.

In one embodiment of the invention, the said running passageway and/orthe said deflection passage is formed of at least one element chosenfrom the group comprising a groove, a slot, a rib or a combination ofthese elements.

Advantageously, the said first and/or second return means areelastically deformable and chosen from the group comprising a helicalspring, an elastic leaf, an elastically deformable element.

As a preference, the said first return means are arranged between theproximal end of the said support and the distal end of the said sleeve.

As a preference, the said sleeve or, respectively, the said supportcomprises at least one stop wall situated facing the said tab when thedevice is in the protection position, the said stop wall being arrangedin such a way as to prevent the radial deflection of the said tabtowards the axis of the said protection device in this protectionposition.

As a preference, the said support is provided with an injection needle.

The present invention also relates to an injection device comprising atleast one injection needle and a reservoir of product that is to beinjected, characterized in that it comprises at least one protectiondevice as described hereinabove.

The present invention also relates to a set comprising a device asdescribed hereinabove and packaging for this device, the said packagingcomprising a cylindrical body and a cap, the said cylindrical body beingequipped on its internal wall with means for blocking the rotation andtranslation of the said device within the said packaging.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in greater detail with theaid of the attached drawings in which:

FIG. 1 is an exploded perspective view of the protection deviceaccording to the invention and of an end of a syringe body,

FIGS. 2 and 5 are, respectively, a side view and a view in section ofthe protection device of FIG. 1 in the storage position and of the endof an injection device,

FIG. 3 is a side view of the protection device of FIG. 1, in theinjection position,

FIG. 4 is a side view of the protection device of FIG. 1 in theprotection position,

FIG. 6 is an exploded perspective view of packaging for the protectiondevice of FIG. 1,

FIGS. 7 to 9 are side views of a second alternative form of embodimentof the protection device according to the invention in the storageposition, the injection position and the protection positionrespectively,

FIGS. 10 to 13 are side views of a third alternative form of embodimentof the protection device according to the invention in the storageposition, the start-of-injection position, the end-of-injection positionand the protection position, respectively,

FIG. 14 is a partial sectioned view of the running passageway of thealternative form of embodiment of FIGS. 10 to 13.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 depicts a protection device 1 for protecting an injection needle2 according to the invention. This protection device 1 comprises asupport 3 for a needle 2 and a sleeve 4 arranged in such a way as toaccept the support 3. This sleeve 4 can be moved in translation withrespect to the support 3, from a storage position depicted in FIG. 2towards a second position, the injection position, depicted in FIG. 3and towards a third position, the protection position, depicted in FIG.4.

In the example depicted, the support 3 and the sleeve 4 each comprisemeans for the guidance and axial translation of the support 3 withrespect to the sleeve 4: in FIG. 1, these guide means are in the form ofdiametrically opposed longitudinal bulges 29 situated on the externalwall of the support 3, these longitudinal bulges 29 collaborating withdiametrically opposed slideways 30 situated on the internal wall of thesleeve 4, facing the said bulges 29.

In FIG. 1, the support 3 comprises a flexible tab 5 which runslongitudinally from the proximal part of the support 3 in the distaldirection. This flexible tab 5 at its distal end comprises a peg 6. Thisflexible tab 5 is able to deflect laterally between a normal positionand at least one stressed deflected position (see FIG. 4). In FIG. 1,this flexible tab 5 is depicted in its normal position. Still in thisfigure, the tab 5 is able to move from its normal position to itsstressed deflected position within a window 7 cut into the wall of thesupport 3. The support 3 comprises a stop wall 8 partially closing offthe window 7, the function of which will be explained later on.

In FIG. 1, the support 3 comprises two proximal fins 9. These fins 9 mayserve to block the rotation and translation of the device of theinvention within its packaging (see FIG. 6) or to lock it in a standard“luer lock” connection system.

In the example depicted, the sleeve 4 comprises a running passageway 10forming a U, made in the wall of the sleeve 4 and arranged in such a wayas to collaborate with the peg 6 over the entire travel of the sleeve,as will be apparent from FIGS. 2-4.

As can also be seen in FIGS. 2-4, the running passageway 10 comprises afirst longitudinal section 11 and a second longitudinal section 12,which are more or less parallel and slightly angularly offset from oneanother about the longitudinal axis of the device 1. These twolongitudinal sections 11 and 12 are connected to one another at theirrespective distal ends by an intermediate section 13.

As depicted in FIG. 1, the protection device 1 also comprises a helicalspring 14. When the device 1 is assembled, as can be seen in FIG. 5, theproximal end 31 of this helical device 14 bears against an internalflange 32 of the proximal part of the support 3 and the distal end 33 ofthe spring 14 bears against the internal face of the radial distal wall15 of the sleeve 4.

The way in which the protection device 1 according to the inventionworks will now be described with reference to FIGS. 2-4.

With reference to FIGS. 2 and 5, the protection device 1 is in thestorage position. The sleeve 4 partially covers the needle 2. Thus, partof the needle 2 is visible for better user control both of the expellingof air and of the phase of positioning the needle 2 on the injectionsite prior to penetration.

In this storage position, the flexible tab 5 (partly concealed by thesleeve 4 in FIG. 2) is in the normal position and the peg 6 is kept inabutment against the proximal end 16 of the first longitudinal section11 of the running passageway 10 by the action of the spring 14 which ispartially compressed between the sleeve 4 and the support 3, as can beseen in FIG. 5.

The protection device 1 is therefore supplied for use in this storageposition. The user then equips himself with the syringe body 17,partially depicted in FIG. 2, prefilled with the medicinal product to beinjected into the injection site. This syringe body 17 comprises astandard distal tip 18 that can be fitted to the proximal base 19 (seeFIG. 1) of the support 3 for connection to the needle 2. The user thusconnects the syringe body 17 to the protection device 1 of theinvention. For simplicity, the syringe body 17 will not be depicted inFIGS. 3 and 4.

Once the syringe body 17 is connected to the protection device 1, theuser begins to cause the needle 2 to penetrate the injection site, untilthe distal radial wall 15 of the sleeve 4 comes into contact with thesurface of the injection site and then be continues, via the syringe 17,to press on the support 3 in order to ensure complete penetration of theneedle 2 in the injection site, the distal radial wall 15 of the sleeve4 still being in contact with the surface of the injection site. Thesleeve 4 therefore moves proximally in the axial direction with respectto the support 3 until the radial peg 6, which takes the path of thefirst longitudinal section 11, comes into abutment against the distalend 20 of this first longitudinal section 11.

The protection device 1 is then in the injection position as depicted inFIG. 3. In such a position, the spring 14 is in the compressed state andthe needle 2 is exposed, that is to say not covered by the sleeve 4because it is inside the injection site.

During the move from the storage position to the injection position, thesleeve 4 has not rotated on itself. The user then proceeds withinjecting the medicinal product from the syringe body 17 in the knownway, maintaining his pressure on the support 3, and the protectiondevice 1 thus remains in the position depicted in FIG. 3.

At the end of injection, the user releases the pressure be was exertingon the support 3 via the syringe and proceeds to withdraw the needle 2from the injection site, thus releasing the spring 14 which returns toits relaxed position carrying with it the support 3 which completelycovers the needle 2. The flexible tab 5 and its radial peg 6 then takethe path marked out by the intermediate section 13 and the secondlongitudinal section 12 of the running passageway 10, as shown in FIG.4.

As can be seen in FIGS. 2-4, the first longitudinal section 11comprises, situated proximally at its distal end 20, a narrowing 21defined by a flexible tongue 39 which allows the peg 6 to pass in thedistal direction and prevents the said peg 6 from returning in theproximal direction. In this embodiment, the flexible tongue 39 forms atleast in part the first safety means, elastically deformable, preventingthe peg 6 from returning from the said second section 12 to the saidfirst section 11.

As the sleeve 4 deploys, when the peg 6 can follow the path marked outby the intermediate section 13 and the second longitudinal section 12 ofthe running passageway 10 by virtue of the ability of the tab 5 todeflect tangentially under stress.

For preference, the flexible tab 5 is made of a deformable andsemi-rigid material such as polypropylene.

Thus, in the protection position as depicted in FIG. 4, the flexible tab5 is in a stressed deflected position and the peg 6 is kept bearingagainst the proximal end 22 of the second longitudinal section 13 by theaction of the spring 14 which is then in the at least partially relaxedposition.

In order to block the protection device 1 in the protection position,the second longitudinal section 12 of the running passageway 10comprises, situated distally at its proximal end 22, a narrowing 23which allows the peg 6 to pass in the proximal direction and preventsthe said peg 6 from returning in the distal direction. As a preference,the peg 6 or the narrowing 23 is able to deform elastically to allowthis passing. There is thus no risk of the needle 2 re-emerging from thesleeve 4. In the example depicted, this narrowing 23 is obtained by thepresence of two steps 24 and 25 situated facing one another on thesecond longitudinal section 12.

In the protection position, as depicted in FIG. 4, the peg 6 faces thestop wall 8 formed in the window 7 of the support 3. This stop wall 8prevents the flexible tab 5 from deflecting radially towards the insideof the support: thus, it is not possible to separate the sleeve 4 fromthe support 3 and to re-expose the needle 2.

In an embodiment, not depicted, the second longitudinal section 12 ofthe running passageway 10 comprises a clearance space which is directedtowards the first longitudinal section 11 and in which the peg 6 becomesblocked in a protection position in which the flexible tab 5 is partlyor completely deflected.

In another undepicted embodiment of the invention, the flexible tab 5 isarranged on the sleeve 4 and the running passageway 10 is formed withinthe wall of the support 3. In yet another embodiment, not depicted, theflexible tab 5 is in a stressed deflected position when the protectiondevice 1 is in the storage position and is in its normal position whenthe protection device 1 is in the protection position. In thisembodiment, the flexible tab 5 forms at least in part the first safetymeans, elastically deformable, preventing the peg 6 from returning fromthe said second section 12 to the said first section 11.

In another embodiment of the invention, not depicted, the sleeve isinside the support.

FIG. 6 depicts packaging 26 for the device 1 of the invention.Specifically, as the needle 2 is partially exposed when the protectiondevice 1 is in the storage position, it is preferable for it to besupplied in protective packaging. The packaging 26 of FIG. 5 comprises acylindrical body 27 and a cap 28. As a preference, the body 27comprises, on its internal cylindrical wall, striations whichcollaborate with the fins 9 of the support 3 to prevent the device 1from rotating within the packaging 26.

The protection device 1 of FIGS. 7 to 9 is similar to the device ofFIGS. 1 to 6. It differs therefrom in that the running passageway 10(depicted in dotted line in FIGS. 7 and 8 and partially in solid line inFIG. 9) is situated on the said support 3 and in that the flexible tabis replaced by a pivoting tab 31 equipped with a pivot connection 32,situated on the sleeve 4. The pivoting of the pivoting tab 31 occurswithin a window 33 of triangular overall shape formed in the wall of thesleeve 4. The running passageway 10 is U-shaped, the second longitudinalsection 12 of the U being longer than the first longitudinal section 11.Thus, the distance 1 ₃ is greater than the distance 1 ₁. The branches ofthe U are separated by a flexible tongue 39.

In the storage position, as depicted in FIG. 7, the peg 6 of thepivoting tab 31 is blocked in the distal end of the first longitudinalsection 11 of the U forming the running passageway 10. Between thestorage position and the injection position, the peg 6 is displacedalong the first longitudinal section 11 where it presses against theflexible tongue 39 and bends it to reach the vertex 36 of the U. Theflexible tongue 39 prevents the peg 6 from coming back to its storageposition and forms at least part of the first safety means. In theinjection position, as depicted in FIG. 8, the pivoting tab 31 haspivoted and the peg 6 is blocked in the vertex 36 of the U that formsthe running passageway 10. In the protection position, as depicted inFIG. 9, the pivoting tab 31 has continued to pivot about the pivotconnection 32 and the peg 6 is blocked in the second longitudinalsection 12 of the U, e.g. at distal end 37, that forms the runningpassageway 10 by a narrowed region, not depicted.

In an undepicted embodiment of the invention, the pivoting tab does notmove in a window; only the peg moves in a deflection passage.

In yet another undepicted embodiment of the invention, the sleeve has nowindow and the tab is superposed on the inside of the wall of thesleeve: thus neither the tab nor the peg move in a window.

The protection device 1 of FIGS. 10 to 14 is similar to the protectiondevice of FIGS. 1 to 6. It differs therefrom in that the peg 6 issubject to the action of a spring 34 which is urged laterally from thefirst longitudinal section 11 towards the second longitudinal section 12of the running passageway 10. The support 3 comprises a deflectionpassage 35 arranged in such a way as to guide the said peg 6 laterally.

Thus, in the storage position, as depicted in FIGS. 10 and 14, the peg 6is blocked against the proximal end of the first longitudinal section 11of the running passageway 10 because of the thrust of the spring 34which is in the compressed state.

In the start-of-injection position, as depicted in FIG. 11, the peg 6arrives in the deflection passage 35 in which it is pushed by the spring34 which relaxes. In this embodiment, the spring 34 forms at least inpart the first safety means, elastically deformable, preventing the peg6 from returning from the said second section 12 to the said firstsection 11.

Thus, when the user withdraws the injection device 1 from the injectionsite, the peg 6 is guided in the second longitudinal section 12 of therunning passageway 10. In the protection position, as depicted in FIG.13, the peg 6 is kept blocked against the proximal end 38 of the secondlongitudinal section 12 of the running passageway 10 by the thrust ofthe spring 34. The needle is perfectly covered by the sleeve. Theinjection device 1 is safe.

As is apparent from the above description, the protection device 1according to the invention allows an injection to be given in completesafety by virtue in particular of the fact that the sleeve 4 thatprotects the needle 2 does not rotate on itself at any time during theinjection process and by virtue of the fact that this sleeve 4 deploysautomatically at the end of the injection without any additional manualoperation on the part of the user. In addition, the reliability of theprotection device 1 according to the invention is increased by thereduced number of parts involved and their reduced relative movementwith therefore enable to limit problems due to friction between movingparts.

The invention claimed is:
 1. A protection device intended to at leastpartially cover an injection needle of an injection device, saidprotection device comprising at least: a support provided with a fixingdevice intended to secure said protection device to the injectiondevice, a sleeve comprising a distal end intended to come into contactwith an injection surface and provided with an orifice intended to allowsaid injection needle to pass, said sleeve being arranged in such a wayas to be moveable axially in translation with respect to said supportfrom a first position known as the storage position, in which the distalend of said sleeve is at a distance 1 ₁ from said fixing device, to asecond position known as the injection position, in which the distal endof said sleeve is at a distance 1 ₂ from said fixing device, and to athird position known as the protection position, in which the distal endof said sleeve is at a distance 1 ₃ from said fixing device, saiddistances 1 ₁ and 1 ₃ being greater than said distance 1 ₂, a firstreturn device for returning said sleeve at least from the injectionposition to the protection position, wherein said protection devicecomprises at least: an axial-guidance device for guiding said sleeve,arranged in such a way as to prevent said sleeve from rotating as saidsleeve moves axially with respect to said support at least from theinjection position to the protection position, at least one peg,directly and at least elastically coupled longitudinally to said supportor to said sleeve and housed in a running passageway provided in theother of said sleeve or said support, said running passageway formingmore or less a U shape including a first section taken by said peg assaid sleeve moves from the storage position to the injection positionand a second section taken by said peg as said sleeve passes from theinjection position to the protection position, said peg being designedto be laterally mobile, a first safety device, at least part of thefirst safety apparatus being elastically deformable, said first safetyapparatus being arranged in such a way as to prevent said peg fromreturning from said second section to said first section, and a secondsafety apparatus arranged in such a way as to block said peg when saidsleeve is in the protection position, said second safety apparatusincluding first and second steps extending into said second section ofsaid running passageway so as to be situated facing one another todefine a first narrowed region which inhibits passage therethrough ofsaid peg.
 2. The protection device according to claim 1, wherein saidaxial-guidance apparatus is arranged in such a way as also to preventsaid sleeve from rotating as said sleeve moves axially with respect tosaid support from the storage position to the injection position.
 3. Theprotection device according to claim 1, wherein said axial-guidanceapparatus comprises more or less complementary longitudinal geometricshapes provided respectively on said sleeve and on said support andarranged facing one another in order to collaborate.
 4. The protectiondevice according to claim 1, wherein said first and second sections ofsaid running passageway are joined together by a second narrowed regiondefined by a flexible tongue at least partially defining said firstsafety apparatus.
 5. The protection device according to claim 1, whereinthe peg is coupled to said support or said sleeve (4) comprises, and atleast one tab able to deflect tangentially and bearing said peg is alsocoupled to the same of the support or the sleeve.
 6. The protectiondevice according to claim 5, wherein said tab is arranged in such a wayas to deflect tangentially in an elastically deformable manner between anormal position and at least one stressed deflected position, said tabat least partially defining said first safety device.
 7. The protectiondevice according to claim 6, wherein said tab is in the normal positionor in the at least one stressed deflected position when said peg is insaid first section, and said tab is in the other of the at least onestressed deflected position or in the normal position when said peg isin said second section.
 8. The protection device according to claim 5,wherein said sleeve or said support comprises at least one stop wallsituated facing said tab when the sleeve is in the protection position,said stop wall being arranged in such a way as to prevent the tangentialdeflection of said tab towards an axis of said protection device in theprotection position.
 9. The protection device according to claim 1,wherein said first and second sections have different lengths arrangedin such a way as to delimit storage and protection positions such thatsaid distance 1 ₃ is greater than said distance 1 ₁.
 10. The protectiondevice according to claim 1, wherein said running passageway is formedof at least one element chosen from the group comprising a groove, aslot, a rib or a combination of these elements.
 11. The protectiondevice according to claim 1, wherein said first return device iselastically deformable and chosen from the group comprising a helicalspring, an elastic leaf, or an elastically deformable element.
 12. Theprotection device according to claim 1, wherein said first return deviceis arranged between a proximal end of said support and the distal end ofsaid sleeve.
 13. The protection device according to claim 1, whereinsaid support is provided with the injection needle.
 14. An injectiondevice comprising at least one injection needle and a reservoir ofproduct that is to be injected, wherein the injection device comprisesat least one protection device according to claim
 1. 15. A setcomprising a protection device according to claim 1 and packaging forthe protection device, said packaging comprising a cylindrical body anda cap, said cylindrical body being equipped on an internal wall with adevice for blocking rotation and translation of said protection devicewithin said packaging.